Vicks® DayQuil™ SEVERE HOT REMEDY COLD & FLU PLUS CONGESTION

Vicks DayQuil Severe Hot Remedy by

Drug Labeling and Warnings

Vicks DayQuil Severe Hot Remedy by is a Otc medication manufactured, distributed, or labeled by Procter & Gamble Manufactura S de RL de CV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VICKS DAYQUIL SEVERE HOT REMEDY COLD AND FLU PLUS CONGESTION- acetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride powder, for solution 
Procter & Gamble Manufactura S de RL de CV

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Vicks® DayQuil™ SEVERE HOT REMEDY COLD & FLU PLUS CONGESTION

Drug Facts

Active Ingredient (in each packet) Purpose

Acetaminophen 650 mg...............................Pain reliever/fever reducer
Dextromethorphan HBr 20 mg...................... Cough suppressant
Guaifenesin 400 mg...................................... Expectorant

Phenylephrine HCl 10 mg............................. Nasal decongestant

Active Ingredient (in each packet) Purpose

Acetaminophen 650 mg.............................Pain reliever/fever reducer
Dextromethorphan HBr 20 mg.................... Cough suppressant
Guaifenesin 400 mg.................................... Expectorant

Phenylephrine HCl 10 mg........................... Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

nasal congestion

sinus congestion & pressure

cough due to minor throat & bronchial irritation

minor aches & pains

headache

fever

sore throat

reduces swelling of nasal passages

temporarily restores freer breathing through the nose

promotes nasal and/or sinus drainage

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make

coughs more productive.

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 6 doses in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy Alert:

Acetaminophen may cause severe skin reactions. Symptoms may include:

  • Skin reddening
  • Blisters
  • Rash

If a skin reaction occurs, stop use and seek medical help right away

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product

do not use more than directed

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

take only as directed

do not exceed 4 doses (one packet each dose) per 24 hrs

Adults & children 12 yrs & over - one packet every 4 hours

Children under 12 yrs - Do not use

dissolve contents of one packet into 8 oz. of hot water and stir briskly; sip while hot. Consume entire drink within 10-15 minutes

if using a microwave, add contents of one packet to 8 oz. of cool water, stir briskly before and after heating. Do not overheat

Other information

each packet contains: potassium 20 mg

phenylketonurics: contains phenylalanine 56 mg per dose

store at no greater than 25°C (77°F)

Inactive ingredients

acesulfame potassium, aspartame, citric acid, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, flavors, silicon dioxide, sucrose

Questions?

1-800-362-1683

MADE IN MEXICO

DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 6 packet package

MAX STRENGTH

Vicks® DayQuil™ SEVERE HOT REMEDY

COLD & FLU + CONGESTION

Acetaminophen - Headache, Fever, Sore Throat, Minor Aches & Pains

Guaifenesin - Chest Congestion, Thins & Loosens Mucus

Phenylephrine HCl - Nasal Congestion, Sinus Pressure

Dextromethorphan HBr - Cough

HONEY LEMON TEAM FLAVOR

Non-Drowsy

6 POWDER PACKETS

976

VICKS DAYQUIL SEVERE HOT REMEDY  COLD AND FLU PLUS CONGESTION
acetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58933-540
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 5 g
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 5 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 g
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 5 g
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ASPARTAME (UNII: Z0H242BBR1)  
SUCROSE (UNII: C151H8M554)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorHONEY (Lemon) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58933-540-015 g in 1 PACKET; Type 0: Not a Combination Product07/20/202203/22/2023
2NDC: 58933-540-088 in 1 PACKAGE07/20/202203/22/2023
25 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01207/20/202203/22/2023
Labeler - Procter & Gamble Manufactura S de RL de CV (812807550)

Revised: 3/2023
 
Procte

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